Platelet-Rich Plasma Versus Home-Based Exercise for Partial-Thickness Supraspinatus Tears
NCT ID: NCT07246434
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2023-09-01
2024-07-31
Brief Summary
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This prospective, controlled study includes two parallel groups. The PRP group receives three monthly ultrasound-guided intratendinous PRP injections, preceded by local anesthesia. The control group follows a structured home-based exercise program for the same overall treatment period. All participants are assessed at baseline and again two months after completing their assigned intervention.
The primary outcome is shoulder pain measured with a Visual Analog Scale (VAS). Secondary outcomes include shoulder range of motion (flexion, extension, abduction, adduction, internal and external rotation) and functional disability measured with the Constant-Murley Score. The study also analyzes whether patient characteristics such as age or sex are associated with clinical improvement.
The aim of this research is to compare two commonly used conservative treatment strategies and provide evidence to guide clinical decision-making for patients with partial-thickness supraspinatus tears.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PRP Injection
Participants receive three monthly ultrasound-guided intratendinous injections of platelet-rich plasma (PRP) in the affected supraspinatus tendon, preceded by local anesthetic infiltration in the subacromial bursa.
Platelet-Rich Plasma (PRP)
Ultrasound-guided intratendinous injection of 4 mL PRP prepared from autologous blood using the BS PRP SYSTEM-20 kit. A total of three injections are administered at one-month intervals. Local anesthesia with 5 mL mepivacaine 2% is applied subacromially prior to PRP administration.
Home-Based Exercise Program
Active Comparator
Home Exercise Program
A supervised-prescribed home-based shoulder exercise program including mobility, strengthening, and scapular stabilization exercises. The program is performed regularly over approximately three months, with progression based on clinical guidelines for rotator cuff rehabilitation.
Interventions
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Platelet-Rich Plasma (PRP)
Ultrasound-guided intratendinous injection of 4 mL PRP prepared from autologous blood using the BS PRP SYSTEM-20 kit. A total of three injections are administered at one-month intervals. Local anesthesia with 5 mL mepivacaine 2% is applied subacromially prior to PRP administration.
Home Exercise Program
A supervised-prescribed home-based shoulder exercise program including mobility, strengthening, and scapular stabilization exercises. The program is performed regularly over approximately three months, with progression based on clinical guidelines for rotator cuff rehabilitation.
Eligibility Criteria
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Inclusion Criteria
Shoulder pain for more than 6 months with a Visual Analog Scale (VAS) score \> 4.
Partial-thickness tear of the supraspinatus tendon confirmed by ultrasound.
No improvement in VAS after conservative treatment with NSAIDs and/or physical therapy during the previous 6 months.
Willingness to undergo blood extraction and PRP infiltrations as required by the protocol.
Exclusion Criteria
Full-thickness tear of the supraspinatus tendon.
Active infection (osteomyelitis, septic arthritis).
Current treatment with NSAIDs, antiplatelet agents, or systemic immunosuppressants.
Severe thrombocytopenia.
Positive serology (syphilis, HIV, HBV, HCV).
20 Years
70 Years
ALL
No
Sponsors
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Universidad de Extremadura
OTHER
Responsible Party
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Carlos Fernández-Morales
Clinical Professor
Principal Investigators
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Luis Espejo-Antúnez, Ph.D.
Role: STUDY_DIRECTOR
University of Extremadura
Locations
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University of Extremadura
Badajoz, Badajoz, Spain
Countries
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Other Identifiers
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10
Identifier Type: -
Identifier Source: org_study_id
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